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EUGENE, OR, United States

Grant
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase II | Award Amount: 499.37K | Year: 2016

DESCRIPTION provided by applicant Epilepsy is a debilitating brain disorder and surgery is the key treatment modality for those patients whose seizures cannot be controlled medically Epilepsy surgery is complex requiring multimodal imaging data for planning and execution and image analysis software is essential for this process The overall goal of this application is to develop a robust commercial software platform for multimodal image analysis for epilepsy surgery that can obtain regulatory approval for clinical use in both academic and non academic hospitals These software tools were developed in part for the needs of our epilepsy research at Yale over the last years under NIH NIBIB funding and in part internally at Electrical Geodesics Inc for the brain segmentation source analysis and display parts of the forthcoming GeoSource software package The innovation in this proposal lies i the development of innovative image analysis methodology that addresses specific needs in epilepsy image analysis and ii the translation of tested research software to a new design that will enable its successful transition via regulatory approval to clinical use The significance of this proposal is that it aims to provide clinically usable epilepsy surgical planning software with explicit support for multimodal image integration and intracranial electrode localization that can be integrated with the image guided navigation systems used for neurosurgery This tool would have a major impact on both surgical planning and image guided epilepsy neurosurgery PUBLIC HEALTH RELEVANCE In the US the lifetime cost of epilepsy for an estimated people with an onset in is projected at $ B and the annual cost for an estimated million prevalent cases is estimated at $ B In many of these cases the treatment procedure requires identifying the abnormal brain region involved and removing it via neurosurgery Epilepsy surgery costs over $ per case and since the surgery is complex and often involves two phases image analysis software is critical to integrate multimodal imaging and EEG recording for pre and intra operative decision support


Grant
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase I | Award Amount: 648.79K | Year: 2016

DESCRIPTION provided by applicant Epilepsy is a debilitating brain disorder and surgery is the key treatment modality for those patients whose seizures cannot be controlled medically Epilepsy surgery is complex requiring multimodal imaging data for planning and execution and image analysis software is essential for this process The overall goal of this application is to develop a robust commercial software platform for multimodal image analysis for epilepsy surgery that can obtain regulatory approval for clinical use in both academic and non academic hospitals These software tools were developed in part for the needs of our epilepsy research at Yale over the last years under NIH NIBIB funding and in part internally at Electrical Geodesics Inc for the brain segmentation source analysis and display parts of the forthcoming GeoSource software package The innovation in this proposal lies i the development of innovative image analysis methodology that addresses specific needs in epilepsy image analysis and ii the translation of tested research software to a new design that will enable its successful transition via regulatory approval to clinical use The significance of this proposal is that it aims to provide clinically usable epilepsy surgical planning software with explicit support for multimodal image integration and intracranial electrode localization that can be integrated with the image guided navigation systems used for neurosurgery This tool would have a major impact on both surgical planning and image guided epilepsy neurosurgery PUBLIC HEALTH RELEVANCE In the US the lifetime cost of epilepsy for an estimated people with an onset in is projected at $ B and the annual cost for an estimated million prevalent cases is estimated at $ B In many of these cases the treatment procedure requires identifying the abnormal brain region involved and removing it via neurosurgery Epilepsy surgery costs over $ per case and since the surgery is complex and often involves two phases image analysis software is critical to integrate multimodal imaging and EEG recording for pre and intra operative decision support


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 128.92K | Year: 2009

DESCRIPTION (provided by applicant): The long-term objective of the proposed project is to design a cost-effective, light-weight, integrated, whole- head EEG/NIR brain imaging and data analysis system for non-invasive recording of brain activity in neonates and young children. This system will permit bedside monitoring of immediate at-risk neonates, and early identification and intervention for abnormalities that predict developmental disabilities and cognitive deficits. A dense-array of 128 combined opto-electrodes sitting on the surface of the scalp will simultaneously record brain electrical activity (electroencephalography, EEG), and cerebral blood oxygenation changes (near-infrared spectroscopy, NIRS), providing complementary measures on the timing and location of brain function. For Phase I, the first Specific Aim is to develop a prototype EEG/NIR sensor net for neonates. Source and sensor opto-electrodes will be assembled into a flexible polymer web (building on EGI's existing geodesic net structure used for 128-channel EEG recording). In addition to housing silver-silver chloride electrodes for EEG acquisition, each source opto-electrode will contain miniature dual-wavelength LEDs for transmitting NIR flux into the head and each detector opto-electrode will contain light detectors and pre-amplifiers for measuring recovered NIR flux (the fractional flux changes being related to changes in oxygenated and deoxygenated hemoglobin concentrations). Miniature shielded wires will connect the opto-electrodes to subsystems that either drive modulated currents to the source LEDs or perform analog-to-digital conversion of the EEG and NIR signals. Multiple unique modulation frequencies will make it possible to drive and distinguish all light sources at detectors using FFT demodulation. EEG, NIR, experimental stimuli, and other recorded physiological signals (e.g., EKG, EMG) will be synchronized using EGI's existing Amp Server technology. Through iterative in-house testing, the infant net and system design will be further refined to improve sensor contact, minimize movement artifact, address comfort and stability, and ensure practical usability of the system as a whole. The second Specific Aim is to field-test the prototype system for data integrity, functionality and usability. Simultaneous resting state EEG and NIR data will be collected on 10 neonates within 24 hours of birth through collaboration with the Subcontractor, who has research privileges at a neonatal hospital unit and expertise in neonatal dense-array EEG. The opto-electrode net will be formally evaluated for fit, safety and comfort, including sensor positioning, contact and pressure, and ease of application. EEG data integrity will be assessed by expert review for comparability to resting EEG data previously collected with EGI's standard HCGSN EEG system in terms of signal quality, and noise and movement artifact. NIRS data integrity will be assessed for fall-off in signal recovery with distance from emitters that is consistent with the computational model of optical diffusion, and for the presence of a readily identifiable cardiac pulse. Aim 3 is to define the architecture for a commercially viable integrated EEG/NIR system for infants and the path for developing it within Phase II. PUBLIC HEALTH RELEVANCE: The goal of this project is to develop the first lightweight device capable of providing real-time spatial and temporal brain imaging information regarding newborn and young infant neural functioning. Such a development would facilitate bedside monitoring of immediate at-risk newborns and offer us the incredible opportunity to identify in very young infants the structural and functional abnormalities that may contribute to later emerging developmental disabilities. Such early identification is vital to the development of early interventions that may mitigate or even preclude the emergence of the disorder.


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 703.45K | Year: 2010

DESCRIPTION (provided by applicant): The long-term objective of the proposed project is to design a low-profile, high-resistive, MRI-compatible dense array EEG sensor net for simultaneous dEEG/fMRI recordings in fields as high as 7 Tesla. This novel sensor net (256-channel InkNet) will use innovative conductive ink leads printed on polymer thick film (PTF) developed at the Analog Brain Imaging Laboratory (ABILAB) at the A. A. Martinos Center of Massachusetts General Hospital. The InkNet will interface with dEEG MRI-compatible hardware and software recently developed at Electrical Geodesics Inc. (EGI). This proposed system will provide safe, noninvasive, and affordable dEEG/fMRI technology to both clinicians and researchers, thereby enabling routine multimodal imaging of human brain function with unprecedented spatiotemporal resolution. Application of this technology will enhance the understanding of healthy brain function, treatment of many neural pathologies, and pre-surgical planning . For Phase I, the first Specific Aim is to modify EEG electrodes for MR-compatible dense-array InkNet recordings. The new InkNet will take advantage of EGI's patented low-profile 256-channel geodesic sensor net (HCGSN) structure. Two electrode designs will be developed and tested. The first will miniaturize the existing 32-channel InkCap half-ring electrodes to fit the HCGSN structure by embedding the electrode directly into the harness design rather than using an adhesive. The alternative design will interface EGI's pellet electrode to PTF ink leads by gluing it to an interface pad printed with polyimide conductive glue. Both designs will be tested using two abrasion-free skin applications: EGI's current electrolyte-soaked sponges and a novel biopotential hydrogel. Performance tests for high signal-to-noise ratio (SNR) and low drift will determine the best electrode design for the Phase I prototype. The Second Specific Aim is to design new PTF traces for efficient routing of the 256 electrode leads. An autorouter program (SPECCTRA) will test nine router parameters to converge on the optimal trace width and length which will then used to determine the number vias and layers required. A fixed trace width of 5 mils to ensure manufacturability will be achieved by testing for spacing violations during the SPECCTRA routing iterations. The final prototype circuits will be printed using a custom mix of carbon and silver inks tested for optimal dielectric and conductive properties. The Third Specific Aim is to test the new dEEG/fMRI system for safety and data integrity. Safety tests will be performed using finite difference time domain (FDTD) numerical simulations with an anatomically accurate head model, followed by actual temperature measurements in the 7T scanner using a specially developed phantom (CHEMA), high-power TSE imaging sequences to induce RF heating, and a four-channel Fluoroptic Thermometer. After confirming safety, MRI and EEG data integrity will be tested at 3T and 7T field strengths using T1-weighted structural sequence, a resting EEG alpha protocol, and a visual processing study. Analyses will contrast MRI quality with and without the InkNet, and EEG quality within and outside the MR scanner. PUBLIC HEALTH RELEVANCE: The goal of this project is to develop a system for simultaneous measurement of brain activity using two complementary methods: electroencephalography (EEG) and functional magnetic resonance imaging (fMRI). This state-of-the-art system will offer brain scientists and clinicians a safe, non-invasive tool for studying human brain function with unprecedented spatial and temporal precision. This knowledge will help us better understand healthy brain function, treat many disorders (e.g., epilepsy), and improve pre-surgical planning.


Patent
Electrical Geodesics, Inc. | Date: 2013-04-16

Methods for use of EIT. Disclosed are: (1) EIT used to obtain a final solution to an EIT inverse problem for localizing tissues undergoing changes in impedance, which is used as a constraint on solving an EEG source localization inverse problem; (2) EIT used with MREIT, where the MREIT is used to constrain the solutions to the EIT inverse problem for the distribution of static tissue impedance; (3) EIT used with MREIT, where the MREIT is used to constrain the solutions to the EIT inverse problem for localizing tissues undergoing changes in impedance; and (4) EIT according to any of (1)-(3) as feedback for modifying at least one of the location, magnitude, and timing of currents injected for the purpose of neurostimulation.

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